(12) United States Patent
`Geitz
`
`USOO6755869B2
`US 6,755,869 B2
`Jun. 29, 2004
`
`(10) Patent No.:
`(45) Date of Patent:
`
`(54) INTRAGASTRIC PROSTHESIS FOR THE
`TREATMENT OF MORBD OBESITY
`
`(75) Inventor: Kurt Geitz, Sudbury, MA (US)
`(73) Assignee: Boston Scientific Corporation, Natick,
`MA (US)
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 60 days.
`
`(*) Notice:
`
`(21) Appl. No.: 10/057,469
`(22) Filed:
`Jan. 25, 2002
`(65)
`Prior Publication Data
`
`US 2003/0109935 A1 Jun. 12, 2003
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 10/007,819, filed on Nov. 9,
`2001, now abandoned.
`(51) Int. Cl.................................................... A61F 2/36
`(52) U.S. Cl. .................................................... 623/23.65
`(58) Field of Search ........................... 623/23.64, 23.65,
`623/23.67, 23.7, 23.75; 604/96.01
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4,648,383 A 8
`3/1987 Angelchik .................. 128/899
`5,306,300 A *
`4/1994 Berry ...................... 623/23.64
`OTHER PUBLICATIONS
`Benjamin, S.B., et al., “Double-Blind Controlled Trial of the
`Garren-Edwards Gastric Bubble: An Adjunctive Treatment
`for Exogenous Obesity,” Gastroenterology 95(3):581–588,
`Sep. 1988.
`Coelho, J.C.U., and Campos, A.C.L., “Surgical Treatment of
`Morbid Obesity,” Current Opinion in Clinical Nutrition and
`Metabolic Care 4(3):201-206, May 2001.
`
`Hubert, H.B., et al., “Obesity as an Independent Risk Factor
`for Cardiovascular Disease: A 26-year Follow-up of Par
`ticipants in the Framingham Heart Study,” Circulation
`67(5):968–977, May 1983.
`Kral, J.G., “Gastric Balloons: A Plea for Sanity in the Midst
`of Balloonacy,” Gastroenterology 95(1):213-215, Jul. 1988.
`Kral, J.G., “Overview of Surgical Techniques for Treating
`Obesity,” American Journal of Clinical Nutrition
`55(2):552S-555S, 1992.
`Macgregor, A.M.C., and Rand, C.S.W., “Gastric Surgery in
`Morbid Obesity,” Archives of Surgery 128(10): 1153–1157,
`Oct. 1993.
`MacLean, L.D., et al., “Results of the Surgical Treatment of
`Obesity,” The American Journal of Surgery 165:155-162,
`Jan. 1993.
`Mathus-Vliegen, E.M.H., et al., “Intragastric Balloon in the
`Treatment of Super-morbid Obesity,” Gastroenterology
`99(2):362-369, Aug. 1990.
`Meshkinpour, H., et al., “Effect of Gastric Bubble as a
`Weight Reduction Device: A Controlled, Crossover Study,”
`Gastroenterology 95(3):589–592, Sep. 1988.
`Mun, E.C., et al., “Current Status of Medical and Surgical
`Therapy for Obesity,” Gastroenterology 120(3):669-681,
`Feb. 2001.
`Pi-Sunyer, F.X., “Medical Hazards of Obesity,” Annals of
`Internal Medicine 119(7):655–660, Oct. 1993.
`* cited by examiner
`Primary Examiner-Corrine McDermott
`Assistant Examiner William H. Matthews
`(74) Attorney, Agent, or Firm-Christensen O'Connor
`Johnson Kindness PLLC
`(57)
`ABSTRACT
`A porous Weave of bioabsorbable filaments having an open
`mesh configuration is formed into an oblate shape having
`dimensions greater than the esophageal opening and gastric
`outlet of a Stomach. The resulting prosthesis is deployed in
`the Stomach and is of a size to be retained in the proximate
`portion thereof for exerting pressure on the upper fundus.
`The prosthesis limits the amount of food that may be held
`within the Stomach, and exerts pressure on the fundus to
`create a Sensation of being full, resulting in weight loSS.
`10 Claims, 2 Drawing Sheets
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`4.
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`Fulfillium Exhibit 2012, Page 1
`ReShape v. Fulfillium
`Case IPR2018-00958
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`U.S. Patent
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`Jun. 29, 2004
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`Sheet 1 of 2
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`US 6,755,869 B2
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`Fulfillium Exhibit 2012, Page 2
`ReShape v. Fulfillium
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`U.S. Patent
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`Jun. 29, 2004
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`Sheet 2 of 2
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`US 6,755,869 B2
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`A2.4
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`Fulfillium Exhibit 2012, Page 3
`ReShape v. Fulfillium
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`1
`INTRAGASTRIC PROSTHESIS FOR THE
`TREATMENT OF MORBD OBESTY
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`This application is a continuation of pending U.S. appli
`cation Ser. No. 10/007,819, filed Nov. 9, 2000 now aban
`doned.
`
`FIELD OF THE INVENTION
`The present invention pertains to a resilient, flexible,
`compressible, biocompatible prosthesis insertable into the
`Stomach to effect weight loSS over a controlled period.
`BACKGROUND OF THE INVENTION
`The incidence of obesity and its associated health-related
`problems have reached epidemic proportions in the United
`States. See, for example, P. C. Mun et al., “Current Status of
`Medical and Surgical Therapy for Obesity” Gastroenterol
`ogy 120:669-681 (2001). Recent investigations suggest that
`the causes of obesity involve a complex interplay of genetic,
`environmental, psycho-behavioral, endocrine, metabolic,
`cultural, and Socioeconomic factors. Severe obesity is fre
`quently associated with Significant comorbid medical
`conditions, including coronary artery disease, hypertension,
`type II diabetes mellitus, gallstones, nonalcoholic
`Steatohepatitis, pulmonary hypertension, and Sleep apnea.
`Estimates of the incidence of morbid obesity are approxi
`mately 2% of the U.S. population and 0.5% worldwide.
`Current treatments range from diet, exercise, behavioral
`modification, and pharmacotherapy to Various types of
`Surgery, with varying risks and efficacy. In general, nonsur
`gical modalities, although less invasive, achieve only rela
`tively short-term and limited weight loSS in most patients.
`Surgical treatments include gastroplasty to restrict the
`capacity of the Stomach to hold large amounts of food, Such
`as by Stapling or “gastric banding.” Other Surgical proce
`dures include gastric bypass and gastric "balloons' which,
`when deflated, may be inserted into the Stomach and then are
`distended by filling with saline solution.
`The need exists for cost effective, less invasive interven
`tions for the treatment of morbid obesity.
`SUMMARY OF THE INVENTION
`The present invention provides a novel System for treat
`ment of morbid obesity by use of a bioabsorbable gastric
`prosthesis placed in the Stomach through a minimally inva
`Sive procedure. The prosthesis takes up Space in the Stomach
`So that the Stomach can hold a limited amount of food, and
`preferably exerts pressure on the upper fundus to create a
`Sensation of being full. The material of the prosthesis can be
`Selected to degrade over a predetermined period and pass out
`of the patient without additional intervention.
`In the preferred embodiment, the prosthesis is a porous
`Weave of bioabsorbable filaments having an open mesh
`configuration. The prosthesis can be formed from a cylin
`drical Stent, Such as by reverting the ends of the cylinder and
`joining them at the center. The filaments preferably have
`memory characteristics tending to maintain an oblate shape
`with Sufficient resiliency and Softness So as not to unduly
`interfere with normal flexing of the Stomach or cause
`abrasion of the mucus coat constituting the inner lining of
`the Stomach. The prosthesis may be free floating in the
`Stomach, but is shaped So as to be biased against the upper
`fundus, or it may be tacked in position adjacent to the funduS
`by bioabsorbable sutures.
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`US 6,755,869 B2
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`2
`BRIEF DESCRIPTION OF THE DRAWINGS
`The foregoing aspects and many of the attendant advan
`tages of this invention will become more readily appreciated
`as the Same become better understood by reference to the
`following detailed description, when taken in conjunction
`with the accompanying drawings, wherein:
`FIG. 1 is a Somewhat diagrammatic elevation of a stom
`ach and adjacent parts of the alimentary canal, with the wall
`adjacent to the viewer partially broken away to reveal an
`intragastric prosthesis in accordance with the present inven
`tion;
`FIG. 2 is a side elevation of a cylindrical stent from which
`a prosthesis in accordance with the present invention may be
`formed;
`FIG. 3 is a Side elevation of a prosthesis in accordance
`with the present invention, formed from the stent of FIG. 2;
`and
`FIG. 4 is a diagrammatic elevation corresponding to FIG.
`1, illustrating insertion of a prosthesis in accordance with the
`present invention through the esophagus and into the Stom
`ach.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENT
`The present invention provides a Volume-filling prosthe
`sis insertable into the stomach for treatment of morbid
`obesity by taking up Space in the Stomach to reduce its
`capacity and by exerting pressure to create a Sensation of
`being full, particularly on the upper fundus.
`FIG. 1 illustrates a central portion of the alimentary canal
`including the distal Segment of the esophagus 10, the Stom
`ach 12, and the duodenum 14 (proximate Segment of the
`Small intestine). The esophagus 10 opens into the Stomach
`12 toward the top of the lesser curvature 16 adjacent to the
`fundus 18. The pyloric part 20 of the stomach leads to the
`duodenum by way of the gastric outlet or pylorus 22 which
`forms the distal aperture of the Stomach and has an enclosing
`circular layer of muscle which is normally contracted to
`close the aperture but which relaxes to provide an open but
`restricted passage. Although Subject to Substantial variation
`in different individuals, representative dimensions for the
`Stomach are approximately 8 cm long (fundus to pylorus) by
`5 cm wide (greatest distance between lesser and greater
`curvatures), with the esophageal opening being approxi
`mately 2 cm in diameter and the pylorus having a maximum
`open diameter of about 2 cm.
`In accordance with the present invention, an oblate,
`volume-filling prosthesis 24 is held within the stomach,
`sized for reception in the proximate portion adjacent to the
`opening of the esophagus and funduS. Such prosthesis
`preferably is a porous body formed of a loose weave of thin
`polymer filaments 26, having large Spaces between filaments
`for an open area of at least about 80%, preferably more than
`90%, so as not to impede the flow of gastric juices or other
`functioning in the Stomach. The filaments 26 have Substan
`tial memory characteristics for maintaining the desired
`oblate shape and size. However, the filaments preferably are
`sufficiently soft and flexible to avoid abrasion of the mucus
`coat forming the inner lining of the Stomach and to enable
`normal flexing and shape changes. The Size of the prosthesis
`24 is Substantially greater than the opening of the esophagus,
`at least about 3 cm in the narrowest dimension, preferably at
`least about 4 cm. The longer dimension of the oblate
`prosthesis is greater than 4 cm, preferably at least about 5 cm
`to prevent the prosthesis from free movement within the
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`Fulfillium Exhibit 2012, Page 4
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`3
`Stomach. The size and shape of the prosthesis tend to
`maintain it in the position indicated in FIG. 1, adjacent to the
`fundus 18 and remote from the pyloric part 20. Thus, while
`the prosthesis occupies a Substantial portion of the Volume
`of the Stomach, preferably approximately one-half the
`Volume, the prosthesis does not interfere with normal diges
`tion of food, Such as by gastric juices (hydrochloric acid and
`digestive enzymes) nor with passage of food through the
`pyloric part 20 and its opening 22 to the duodenum 14.
`With reference to FIG. 2, the prosthesis can be formed
`from a substantially cylindrical stent 28 having the desired
`porous Weave and large open area. The filaments 26 and
`Weave pattern are Selected to achieve memory characteris
`tics biasing the prosthesis to the cylindrical condition
`shown. In the preferred embodiment, the opposite ends 30 of
`the Stent are reverted, the end portions are rolled inward, and
`the ends are Secured together Such as by Suturing.
`Alternatively, a disk of the same pattern and material can be
`used in Securing the reverted ends together. The resiliency of
`the filaments tends to bulge the resulting prosthesis 26
`outward to the desired oblate shape.
`Prior to reversion of the ends, stent 28 in the condition
`shown in FIG. 2 can be approximately 2-3 cm in diameter
`and approximately 8-10 cm long, in a representative
`embodiment. The filaments can have a diameter of about
`0.010 inch to about 0.25 inch. The filaments may be coated
`or impregnated with other treating agents, Such as appetite
`SuppreSSants, or agents to decrease the likelihood of gastric
`problems, Such as ulcers, due to the presence of a foreign
`object. However, such problems are unlikely due to the
`biocompatible nature and the resilient flexibility of the
`prosthesis.
`It is preferred that the filaments 26 be formed of a
`bioabsorbable polymer Such as a polyglycolic acid polymer
`or polylactic acid polymer. Similar materials are used for
`Some bioabsorbable Sutures having “forgiving memory
`characteristics and Sufficient “Softness” that tissue abrasion
`is inhibited. The absorption characteristics of the filaments
`26 can be Selected to achieve disintegration of the prosthesis
`26 within the range of three months to two years, depending
`on the severity of obesity. In the preferred embodiment, the
`prosthesis will absorb and pass naturally from the Stomach
`approximately 6 months after deployment.
`Nonbioabsorbable materials may be used, such as Nitinol,
`which exhibit the desired springiness but which would
`require that the prosthesis be retrieved. An advantage of the
`preferred, bioabsorbable embodiment of the invention is that
`delivery can be through the esophagus, with no additional
`intervention being required.
`With reference to FIG. 4, preferably from the condition
`shown in FIG. 3, the prosthesis 26 can be compressed to a
`generally cylindrical shape having a diameter of no more
`than about 2 cm Such that the compressed prosthesis can be
`carried in a short (approximately 5 cm to 6 cm long) loading
`tube 32. The loading tube can be advanced along the
`esophagus by a central tube 34 of Smaller diameter, under
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`the Visualization allowed by a conventional endoscope 36.
`The tube 34 can enclose a core wire 38 to actuate a pusher
`mechanism 40 for ejecting the prosthesis 26 when the
`opening of the esophagus into the Stomach has been reached.
`The endoscope and deployment mechanism can then be
`retracted.
`While the preferred embodiment of the invention has been
`illustrated and described, it will be appreciated that various
`changes can be made therein without departing from the
`Spirit and Scope of the invention. For example, while it is
`preferred that the prosthesis be sized for self-retention in the
`desired position in the Stomach, it also may be Secured in
`position by a few Sutures applied endoscopically, preferably
`in or adjacent to the fundus area of the Stomach.
`The embodiments of the invention in which an exclusive
`property or privilege is claimed are defined as follows:
`1. An intra-gastric prosthesis comprising an empty porous
`oblate body formed of a weave of flexible, resilient filaments
`and sized for reception in a Stomach, the size of the oblate
`body, when deployed in a Stomach, being greater than the
`esophageal opening and the gastric outlet for retention in the
`Stomach, the body being formed of a generally cylindrical
`stent of the filaments with opposite ends of the stent reverted
`and Secured together.
`2. The prosthesis defined in claim 1, in which the fila
`ments are bioabsorbable, So that the prosthesis will pass
`from a stomach without Surgical intervention after an
`approximately predetermined period.
`3. The prosthesis defined in claim 2, in which the approxi
`mately predetermined period is 3 months to 2 years.
`4. The prosthesis defined in claim 3, in which the approxi
`mately predetermined period is about Six months.
`5. The prosthesis defined in claim 1, in which the fila
`ments form a body having an open area of at least 80%.
`6. The prosthesis defined in claim 5, in which the fila
`ments form a body having an open area of at least 90%.
`7. The prosthesis defined in claim 1, in which the body is
`sized for reception in the proximate portion of the Stomach
`adjacent to the fundus for applying pressure to the fundus.
`8. The prosthesis defined in claim 1, in which the body is
`formed of filaments coated or impregnated with a medical
`treating agent Selected from the group consisting of appetite
`SuppreSSants and agents to decrease the likelihood of gastric
`problems.
`9. The prosthesis defined in claim 1, in which the body is
`compressible to a generally cylindrical shape having a
`diameter of no more than out 2 cm.
`10. The prosthesis defined in claim 9, and mechanism for
`deploying the body in a Stomach, Such mechanism including
`a loading member for receiving the body in compressed
`condition, an advancing member for moving the loading
`member along the esophagus, and a deployment mechanism
`for ejecting the body into the stomach whereby the body
`expands due to memory characteristics of the filaments.
`
`Fulfillium Exhibit 2012, Page 5
`ReShape v. Fulfillium
`Case IPR2018-00958
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. : 6,755,869 B2
`DATED
`: June 29, 2004
`INVENTOR(S) : K. Geitz
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is
`hereby corrected as shown below:
`
`Column 4
`Line 48, 'out' should read -- about --
`
`Signed and Sealed this
`
`Twelfth Day of October, 2004
`
`WDJ
`
`JON W. DUDAS
`Director of the United States Patent and Trademark Office
`
`Fulfillium Exhibit 2012, Page 6
`ReShape v. Fulfillium
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